Electrical Inhibition (EI): A Preliminary Study To Inhibit Preterm Labor And Preterm Birth

NCT ID: NCT02569216

Last Updated: 2017-11-09

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-09
• Study Completion Date: 2016-08-15

Brief Summary

An electrical-inhibition (EI) uterine pacemaker device similar to an electrical heart pacemaker delivers a weak electrical current to the human uterus during active preterm labor to rapidly and safely inhibit the unwanted premature uterine contractions and possibly a preterm birth.

Detailed Description

Electrical intervention (EI) uses bipolar, constant-current (1-20 mA), square-wave pulses in 20% duty cycles. Women in active preterm labor have an electrode catheter placed into the posterior fornix of the vaginal canal. The EI current is given up to 80 minutes while monitoring tocodynamometric (toco) contractions and adjunct electrohysterographic (EHG) activity while continuously monitoring maternal vital signs, fetal heart rate and electrocardiogram (fECG). The study includes a pre-EI control period (C1); the EI period, when a 10-second current burst is delivered only during a contraction; and a post-EI control period (C2). The whole study will take a maximum of two hours.

The uterine toco contraction frequency and adjunct EHG electrical activity are analyzed for changes caused by EI. Changes in maternal vital signs, fetal heart rate and fECG will determine EI side-effects.

Conditions

Premature Birth; Premature Labor

Keywords

Electrical Inhibition; Preterm Birth; Premature Birth; Preterm Labor; Premature Labor; tocolytic; uterus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Electrical Inhibition (EI) intervention

Electrical Inhibition (EI) uterine pacemaker is activated only when there is a preterm uterine contraction. The EI uterine pacemaker delivers a 1-15mA (20mA maximum) constant direct current for only 2 seconds only while there is a preterm uterine contraction.

Group Type: EXPERIMENTAL

Electrical Inhibition (EI)

Intervention Type: DEVICE

constant direct current 1-20mA transvaginal 10 second bursts only when needed

Interventions

Electrical Inhibition (EI)

constant direct current 1-20mA transvaginal 10 second bursts only when needed

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• between 24 to 34 weeks pregnant with a singleton gestation;
• in preterm labor as defined by the American College of Obstetricians and Gynecologists and the American Academy of Pediatrics,78 as follows:

• persistent uterine contractions (4 every 20 minutes or 8 every 60 minutes)
• And any one or more of the following:

• Documented cervical change
• > 1cm cervical dilatation and progressing
• > 80% cervical effacement
• anticipate a normal spontaneous vaginal delivery (NSVD).
• at least 18 years of age
• signed a written Informed Consent Document
• willing and able to comply with study requirements

Exclusion Criteria

• severe preeclampsia
• severe abruption placenta
• rupture of amniotic membranes
• frank chorioamnionitis
• fetal death
• fetal anomaly incompatible with life
• severe fetal growth restriction (EFW <5%)
• mature fetal lung studies
• maternal cardiac arrhythmias
• a permanent cardiac pacemaker
• a fetal cardiac arrhythmia
• contraindication for tocolysis

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey Karsdon, M.D.

Role: STUDY_DIRECTOR

New York University Hospital

Locations

New York University Hospital

Manhattan, New York, United States

Countries

United States

References

Karsdon J, Garfield RE, Shi SQ, Maner W, Saade G. Electrical inhibition of preterm birth: inhibition of uterine contractility in the rabbit and pup births in the rat. Am J Obstet Gynecol. 2005 Dec;193(6):1986-93. doi: 10.1016/j.ajog.2005.05.009.

Reference Type: RESULT

PMID: 16325601 (View on PubMed)

Karsdon J, El Daouk M, Huang WM, Ashmead GG. Electrical pacemaker as a safe and feasible method for decreasing the uterine contractions of human preterm labor. J Perinat Med. 2012 Nov;40(6):697-700. doi: 10.1515/jpm-2012-0136.

Reference Type: RESULT

PMID: 23089601 (View on PubMed)

Other Identifiers

G080036

Identifier Type: OTHER

Identifier Source: secondary_id

15-00553

Identifier Type: -

Identifier Source: org_study_id